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Serving leading biopharmaceutical companies globally:

Merck
Cipla
Farmers Insurance
Teva
Medtronic
QuintilesIMS
Queensland Health
Julphar
Chubb
UBS

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090951

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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex, Breckenridge Pharm, Sandoz Inc, Somerset Theraps Llc, and Sun Pharm Inds, and is included in six NDAs. It is available from five suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.
Summary for 090951
Tradename:EPINASTINE HYDROCHLORIDE
Applicant:Somerset Theraps Llc
Ingredient:epinastine hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 090951
Suppliers and Packaging for NDA: 090951
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINASTINE HYDROCHLORIDE epinastine hydrochloride SOLUTION/DROPS;OPHTHALMIC 090951 ANDA Somerset Therapeutics, LLC 70069-008 70069-008-10 10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Medtronic
Healthtrust
UBS
US Army
Farmers Insurance
QuintilesIMS
Express Scripts

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